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Co-Diagnostics, Inc. Reports First Quarter 2024 Financial Results

SALT LAKE CITY, May 9, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX) ("Co-Dx," or the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the quarter ended March 31, 2024.

First Quarter 2024 Financial Results:

  • Revenue of $0.5 million, down from $0.6 million during the prior year. Grant revenue totaled $0.2 million while product revenue totaled $0.3 million
  • Operating expenses of $10.5 million increased by 4.4% from the prior year due to an increase in research and development costs incurred for the development of tests currently in our pipeline
  • Operating loss of $10.3 million compared to operating loss of $10.0 million in Q1 2023
  • Net loss of $9.3 million, compared to net loss of $5.8 million in the prior year, representing a loss of $0.31 per fully diluted share, compared to a loss of $0.20 per fully diluted share in the prior year
  • Adjusted EBITDA loss of $8.4 million compared to $7.2 million in Q1 2023
  • Cash, cash equivalents, and marketable securities of $50.0 million as of March 31, 2024

First Quarter and Recent 2024 Business Highlights:

  • Appointed Richard Abbott as President of Co-Diagnostics. Also appointed David Nielsen as Chief Operations Officer (COO), Christopher Thurston as Chief Technology Officer (CTO), and Seth Egan as Chief Commercialization Officer (CCO)
  • Inaugurated a new manufacturing facility in South Salt Lake to manufacture our patented Co-Primers® oligonucleotides, the Co-Dx™ PCR Pro™ instrument, and test cups for the new Co-Dx PCR platform
  • Delivered a keynote address at the 5th Annual MarketsandMarkets conference in London, which included an update of continued expansion of the CoSara manufacturing facility in India to enable greater capacity for in-house manufacturing of reagents, equipment and consumables, along with the ability to manufacture Co-Primers

"We are extremely encouraged by our first quarter progress and believe that we are well positioned to meet our 2024 goals," said Dwight Egan, Co-Diagnostics' Chief Executive Officer. "Co-Diagnostics was pleased to announce the opening of our new manufacturing facility in Salt Lake and continued facility expansion in India, which will soon enable in-house Co-Primers, instrument, and test manufacturing at a low cost. We remain committed to delivering a 510(k) submission to the FDA for our new instrument and COVID-19 test kit in the near future and driving development of our TB, multiplex respiratory, and HPV tests throughout the remainder of the year."

"This is an exciting time for Co-Diagnostics and we truly believe in the disruptive and unique nature of our new platform. We look forward to beginning clinical evaluations for our multiplex test later this year and plan to provide updates on our new platform and pipeline progress as they come," said Brian Brown, Co-Diagnostics' Chief Financial Officer.  

Conference Call and Webcast
Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors. The conference call and webcast will be available via:

Webcast: ir.co-dx.com on the Events & Webcasts page

Conference Call: 844-481-2661 (domestic) or 412-317-0652 (international)

The call will be recorded and later made available on the Company's website: https://co-dx.com.

*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.

About Co-Diagnostics, Inc.:

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease.

Non-GAAP Financial Measures:

This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, income tax (benefit) expense, net interest (income) expense, realized gains on investments, and stock-based compensation. The Company believes that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company's management uses this non-GAAP measure to compare the Company's performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company's financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.

Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the Company's financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company's business.

Forward-Looking Statements:

This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include statements that our expansion in India will soon enable in-house manufacturing at a low cost, our commitment to deliver a 510(k) submission to the FDA for our new instrument and COVID-19 test kit in the near future, and our plan to begin clinical evaluations for our multiplex test later this year. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 14, 2024, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)




March 31, 2024



December 31, 2023


Assets









Current assets









Cash and cash equivalents


$

23,099,251



$

14,916,878


Marketable investment securities



26,864,435




43,631,510


Accounts receivable, net



434,868




303,926


Inventory, net



1,549,812




1,664,725


Income taxes receivable



-




26,955


Prepaid expenses and other current assets



1,750,467




1,597,114


Total current assets



53,698,833




62,141,108


Property and equipment, net



3,183,116




3,035,729


Operating lease right-of-use asset



2,758,757




2,966,774


Intangible assets, net



26,328,000




26,403,667


Investment in joint venture



702,427




773,382


Total assets


$

86,671,133



$

95,320,660


Liabilities and stockholders' equity









Current liabilities









Accounts payable


$

2,027,607



$

1,482,109


Accrued expenses



1,324,779




2,172,959


Operating lease liability, current



859,912




838,387


Contingent consideration liabilities, current



750,877




891,666


Deferred revenue



306,477




362,449


Total current liabilities



5,269,652




5,747,570


Long-term liabilities









Income taxes payable



679,018




659,186


Operating lease liability



1,931,164




2,152,180


Contingent consideration liabilities



438,638




748,109


Total long-term liabilities



3,048,820




3,559,475


Total liabilities



8,318,472




9,307,045


Commitments and contingencies (Note 10)









Stockholders' equity









Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively



-




-


Common stock, $0.001 par value; 100,000,000 shares authorized; 36,127,096 shares issued and 31,278,418 shares outstanding as of March 31, 2024 and 36,108,346 shares issued and 31,259,668 shares outstanding as of December 31, 2023



36,127




36,108


Treasury stock, at cost; 4,848,678 shares held as of March 31, 2024 and December 31, 2023, respectively



(15,575,795)




(15,575,795)


Additional paid-in capital



98,379,651




96,808,436


Accumulated other comprehensive income



226,555




146,700


Accumulated earnings (deficit)



(4,713,877)




4,598,166


Total stockholders' equity



78,352,661




86,013,615


Total liabilities and stockholders' equity


$

86,671,133



$

95,320,660


 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(Unaudited)




Three Months Ended March 31,




2024



2023


Product revenue


$

252,745



$

601,957


Grant revenue



215,109




-


Total revenue



467,854




601,957


Cost of revenue



234,505




502,241


Gross profit



233,349




99,716


Operating expenses









Sales and marketing



1,563,682




1,706,331


General and administrative



2,918,803




3,013,965


Research and development



5,679,678




5,014,060


Depreciation and amortization



330,573




316,010


Total operating expenses



10,492,736




10,050,366


Loss from operations



(10,259,387)




(9,950,650)


Other income, net









Interest income



362,733




202,372


Realized gain on investments



228,070




418,082


Gain on remeasurement of acquisition contingencies



450,260




1,037,672


Gain (loss) on equity method investment in joint venture



(70,955)




277,322


Total other income, net



970,108




1,935,448


Loss before income taxes



(9,289,279)




(8,015,202)


Income tax provision (benefit)



22,764




(2,259,811)


Net loss


$

(9,312,043)



$

(5,755,391)


Other comprehensive loss









Change in net unrealized gains on marketable securities, net of tax



79,855




178,621


Total other comprehensive income


$

79,855



$

178,621


Comprehensive loss


$

(9,232,188)



$

(5,576,770)











Loss per common share:









Basic and diluted


$

(0.31)



$

(0.20)


Weighted average shares outstanding:









Basic and diluted



29,842,874




29,483,540


 

CO-DIAGNOSTICS, INC. AND SUBSIDIARIES

GAAP AND NON-GAAP MEASURES

(Unaudited)


Reconciliation of net loss to adjusted EBITDA:




Three Months Ended March 31,




2024



2023


Net loss


$

(9,312,043)



$

(5,755,391)


Interest income



(362,733)




(202,372)


Realized gain on investments



(228,070)




(418,082)


Depreciation and amortization



330,573




316,010


Change in fair value of contingent consideration



(450,260)




(1,037,672)


Stock-based compensation expense



1,571,234




2,168,742


Income tax provision (benefit)



22,764




(2,259,811)


Adjusted EBITDA


$

(8,428,535)



$

(7,188,576)


 

SOURCE Co-Diagnostics

For further information: Andrew Benson, Head of Investor Relations, +1 801-438-1036, investors@codiagnostics.com